Status:
COMPLETED
National Project on Vaccines, COVID-19 and Frail Patients
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Istituto Clinico Humanitas
Conditions:
COVID-19
Solid Tumor
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicentre observational study with the aim of evaluating the antibody and cellular response after vaccination for SARS-CoV-2 with Pfizer-BioNTech or Moderna vaccines in frail subjects with...
Detailed Description
The immune response to COVID-19 vaccination will be assessed at the following time points: T0: the day of vaccination T1: the day of the booster dose according to the schedule of the two vaccines (Pf...
Eligibility Criteria
Inclusion
- Any subject undergoing SARS-CoV-2 vaccination with Pfizer-BioNTech or Moderna vaccines may be included in the study if they belong to at least one of the subgroups listed below:
- Hematological tumors
- Solid tumors
- Rheumatological diseases
- Neurological diseases
Exclusion
- NA
Key Trial Info
Start Date :
April 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
747 Patients enrolled
Trial Details
Trial ID
NCT04848493
Start Date
April 19 2021
End Date
December 31 2022
Last Update
June 13 2025
Active Locations (12)
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1
IRCCS Istituto Tumori Giovanni Paolo II
Bari, Bari, Italy
2
IRCCS Azienda Ospedaliera Universitaria
Bologna, Bologhna, Italy
3
Ospedale Policlinico San Martino IRCCS
Genova, Genova, Italy
4
Foindazione IRCCS Istituto Neurologico Carlo Besta
Milan, Milano, Italy